FDA issues at-home and OTC COVID-19 testing template

Regulatory NewsRegulatory News | 29 July 2020 |  By 

Developers of COVID-19 diagnostic tests designed for at-home and over-the-counter use have a new template they can use to submit emergency use authorization (EUA) requests to the US Food and Drug Administration (FDA).
For at-home testing, the template includes recommendations for developers in the scenario where samples are collected, analyzed, and results returned without the sample being sent to a laboratory for analysis. Additional validation recommendations are provided in the template for tests available without a prescription.
Providing the template, said FDA, is a step toward having tests available during the pandemic that can be performed entirely outside of a clinical setting; in addition to home-based testing, schools and workplaces may benefit from these types of tests.
“The FDA continues to help facilitate innovation in test development, thereby enhancing Americans’ access to COVID-19 tests,” said FDA Commissioner Stephen M. Hahn, MD. “The recommendations provided today are intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test.”
The template includes recommended sensitivity and specificity thresholds for these types of tests. FDA notes that though the recommended sensitivity is lower than lab-based tests that have received EUAs, “the tremendous benefits of broader access to simple and fast testing options generally outweighs this risk.”
The recommended specimens specified in the template are respiratory secretions or saliva; FDA requests that developers contemplating other specimen sources (such as blood or stool) contact the Center for Devices and Radiologic Health to work out a validation strategy.
The template also asks the develop to specify the intended measurand, which would either be the specific nucleic acid sequences from the SARS-CoV-2 genome or specific antigens from the virus. Developers will be asked to describe the planned reporting method, including a mobile smartphone app or website access. However, FDA says it intends to be flexible in considering novel or innovative reporting methods.
Recommendations in the template for interpretation of results take into account that a lay person may be reading the results, so “results that are displayed to the user should be simple and easy to interpret.” Developers should also explain if, and how, they plan to report results to local health authorities, and whether de-identified information will be transmitted to the US Centers for Disease Control and Prevention (CDC).
“We hope that with the innovation we’ve seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available,” said Hahn. “These types of tests will be a game changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”



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Tags: coronavirus, FDA, US

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